Innovation without Imitation: Utilizing U.S. FDA Drug Master Files | CPhI North America

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Innovation without Imitation: Utilizing U.S. FDA Drug Master Files

Melissa Sayers, M.S. (Senior Regulatory Specialist, Drug Division, Registrar Corp)

Uma Kale (Regulatory Compliance Manager, DuPont)

Location: E353c

Date: Wednesday, May 1

Time: 11:45am - 12:30pm

Track: Drug Manufacturing

Vault Recording: TBD

Registrar Corp’s Melissa Sayers will present on new U.S. FDA electronic common technical document (“eCTD”) requirements for Drug Master Files (DMFs). Attendees will learn the benefits of utilizing DMFs for their products as well as the regulatory requirements for employing DMFs.
Innovative ideas need protection from competitors. Drug companies submit DMFs to FDA to provide confidential information about facilities, processes, or articles. The DMF holder can then authorize others to use the information within the DMF submission in support of NDA, ANDA, and other FDA submissions without disclosing the information to anyone other than FDA.
Once companies with innovative new ingredients, coatings, packaging, etc. are able to navigate the regulatory requirements of DMFs, they can utilize a DMF to incorporate their innovative products in others’ drug products without subjecting their innovation to imitation.

Presentation File